PRELUDE PF 110018154

GUDID 00880304676046

Biomet Sports Medicine, LLC

Patellofemoral joint prosthesis
Primary Device ID00880304676046
NIH Device Record Key00f7bb65-2f30-42b7-bfbb-1d1c4bdc9fd4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRELUDE PF
Version Model Number110018154
Catalog Number110018154
Company DUNS627100159
Company NameBiomet Sports Medicine, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304676046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-11-03

On-Brand Devices [PRELUDE PF]

00880304712720010001760
00880304712713010001759
00880304712706010001757
00880304712690010001756
00880304712683010001755
00880304712676010001752
00880304712669010001751
00880304712652010001750
00880304712645010001749
00880304712638010001748
00880304712621010001747
00880304712614010001693
00880304712607010001692
00880304712591010001690
00880304712584010001689
00880304676855110018152
00880304676848110018151
00880304676824110018149
00880304676817110018148
00880304676077110018164
00880304676060110018156
00880304676053110018155
00880304676046110018154
00880304676039110018153
00880304567726110005120
00880304567719110005119
00880304567702110005118
00880304567696110005117
00880304567689110005116
00880304567672110005115
00880304567504110004335
00880304567498110004334
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00880304567474110004332
00880304567467110004331
00880304567450110004330
00880304567351110004179
00880304567344110004178
00880304567337110004177
00880304567320110004176
00880304567313110004175
00880304567306110004174
00880304567290110004173
00880304567276110004171
00880304567245110004167
00880304567221110004163
00880304567214110004162
00880304567207110004160
00880304567191110004158
00880304567184110004157

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